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Friday, October 25, 2013

Progress in Multiple Sclerosis-ECTRIMS 2013

Andrew Wilner, MD, Neurology, 10:08AM Oct 8, 2013

Introduction

I’ve just returned from the 29th European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Copenhagen, Denmark, and learned that advances in the understanding and treatment of multiple sclerosis (MS) continue at a dizzying pace. Patients now have the option of injectable therapy with interferons (Avonex, Betaseron, Extavia, or Rebif), glatiramer acetate (Copaxone), three different oral drugs [(dimethyl fumarate (Tecfidera), fingolimod (Gilenya), teriflunomide (Aubagio)], and an infusion therapy, natalizumab (Tysabri). Alemtuzumab (Campath, Lemtrada), a humanized monoclonal antibody that targets CD52 on lymphocytes and monocytes has received approval in Europe. Barring regulatory snafus at the U.S. Food and Drug Administration, alemtuzumab will soon become available in the US. In addition, second generation orals are already in development.

ECTRIMS 2013

Refining Standard Treatment

Technological advances are making older treatments safer and more convenient. JC virus screening and perhaps other types of testing such as L-Selectin (CD62L) levels, may circumvent the knotty problem of progressive multifocal leukoencephalopathy associated with natalizumab, vastly improving this drug's safety. First year results from the ADVANCE study suggest that peginterferon beta-1a may allow bimonthly injections, likely to dramatically improve patient acceptance. Autoinjectors for interferons have been modified for ease of use, and at least one injector has the ability to store data to assist with assessing compliance.

Improvements in Imaging and Understanding

Ultra-high field 7.0 Tesla magnets provide higher resolution images of grey and white matter and improved spectroscopy that are enabling additional insights into MS pathophysiology. Optical coherence tomography (OCT) allows a noninvasive look into the integrity of the retinal nerve fiber layer of the optic nerve and may have some use as a surrogate marker of disease progression. Advances in neuroimmunology and genetics are propelling our understanding of MS towards the day when designer drugs may completely eliminate symptoms and progression.

Unprecedented Growth

I’ve had the opportunity to attend ECTRIMS meetings for the last several years. (See articles here, here and here.) ECTRIMS 2013 had approximately 7,000 attendees and over 1,000 scientific presentations in contrast to ECTRIMS 2003, which had only 3,000 delegates and a mere 500 presentations. The first ECTRIMS meeting, in 1982, just over 30 years ago, had only 50 attendees.

A New Paradigm

Residents of my era were admonished by their attendings to “know the literature.” One was expected to recite results from important reports in the New England Journal of Medicine, Neurology, or Annals of Neurology on rounds. Even 25 years ago it was a daunting task, but seemed achievable if only one was dedicated enough. Today the training paradigm has distinctly changed. I had the opportunity to speak to an Oxford medical student and a resident, both of whom presented papers at the prestigious late-breaking news session on the last morning of the ECTRIMS Congress. I was struck by their ready acknowledgement that there was clearly too much to learn, even in their narrow research areas. One can only forge ahead, study the papers most relevant to one’s research, and proceed knowing that there is a huge amount of information that one will inadvertently overlook. Today's students are never more than an arm's reach away from their smartphones or computers and the world's largest digital libraries. Constant internet access has replaced dusty library stacks. (At least they aren’t wasting their evenings and weekends at the library feeding mountains of quarters into overheated Xerox machines in order to photocopy journal articles...)

The Future

The progress in MS research is a fantastic phenomenon that has already revolutionized the treatment of this complex disorder. The number of participants and abstracts at international meetings like ECTRIMS has grown dramatically, increasing the challenges of staying abreast of important developments. Few, if any, attendees will have the fortitude to view every poster and attend all the lectures. This places a heavy responsibility on those who write summaries, perspective articles and commentaries to ensure that their reports are accurate, balanced, concise, and well written. Even more importantly, these encapsulations must be interesting, or few will invest their spare and fleeting moments to read them!

References

Bates, D. 10 years of progress. Report from selected presentations at the 19th ECTRIMS Congress, 17-20 September 2003, Milan, Italy. The International MS Journal 2003;10:121.

COPENHAGEN, Denmark — Latest results from the clinical trial program with BG-12 (dimethyl fumarate; Tecfidera, Biogen Idec) suggest sustained clinical efficacy and safety in patients with multiple sclerosis (MS) taking the drug for up to 4 years.

In addition, a separate post hoc analysis of the phase 3 pivotal Determination of the Efficacy and Safety of Oral Fumarate in Relapsing–Remitting MS (DEFINE) and Comparator and an Oral Fumarate in Relapsing–Remitting Multiple Sclerosis (CONFIRM) clinical trials shows that BG-12 reduced relapses and disease activity in treatment-naive patients.

The latest long-term results come from the ENDORSE study, an extension phase of the DEFINE and CONFIRM trials.

Commenting on these results for Medscape Medical News, Bernd Kieseier, MD, Heinrich Heine University, Düsseldorf, Germany, who did a talk rounding up meeting highlights including these new results, said, "These are reassuringly meaningful clinical results showing that the effects of BG-12 over 2 years are maintained in the third and fourth year, with no additional safety concerns."

Ralf Gold, MD, St. Josef-Hospital/Ruhr-University in Bochum, Germany, a leading investigator in the extension study, said, "When making MS treatment decisions, we weigh efficacy and safety considerations, so it is encouraging to see that the positive profile of BG-12 observed in the DEFINE and CONFIRM studies has been maintained in the ENDORSE clinical trial to date."

These data were presented at the recent 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Newest Oral Therapy

BG-12 is one of the new oral therapies for multiple sclerosis. It was approved by the US Food and Drug Administration in the United States and is going through the reimbursement process in Australia and Canada.

In Europe, regulatory authorities are still reviewing the drug, with "data exclusivity" discussions ongoing. Biogen told Medscape Medical News that it has strong patent protection for the product, but the company is in discussions with the European authorities on regulatory data protection "to ensure maximum coverage is in place."

Researchers have identified a bacterial toxin that they believe may be a trigger for multiple sclerosis (MS).

Their study, published in the October issue of PLoS ONE, is the first to identify the culprit bacterium, Clostridium perfringenstype B, in humans, and to single out the toxin it produces — known as epsilon toxin — as a probable MS trigger.

The researchers, from the Weill Cornell Medical College and The Rockefeller University in New York, New York, describes discovery of C perfringens type B in a 21-year-old woman who was experiencing a flare-up of her MS.

"That we identified this bacterium in a human is important enough, but the fact that it is present in MS patients is truly significant because the toxin targets the exact tissues damaged during the acute MS disease process," said lead author, Kareem Rashid Rumah, an MD/PhD student at Weill Cornell Medical College.

For the study, the researchers screened serum and spinal fluid from 30 patients with MS and 31 healthy controls. They found that 10% of the patients with MS had antibodies to an epsilon toxin compared with just 1% of controls.

Senior investigator, Timothy Vartanian, MD, Weill Cornell Medical College, commented to Medscape Medical News: "We know from the veterinary literature that if animals are vaccinated against C perfringens type B, their immunity drops off very quickly. So the 10% figure is probably lower than the real incidence. We believe the exposure is much higher than the seroreactivity is telling us."

The team also examined stool samples from both patients with MS and healthy controls enrolled in the HITMS (Harboring the Initial Trigger of Multiple Sclerosis) clinical study and found that 52% of healthy controls carried the A subtype compared with 23% of patients with MS.

"This is important because it is believed that the type A bacterium competes with the other subtypes for resources, so that makes it potentially protective against being colonized by epsilon toxin–secreting subtypes and developing MS," Dr. Vartanian noted.

Evidence Supporting a Trigger

He says substantial evidence supports the idea of an environmental trigger necessary for MS to begin. "There are many datasets that point to this." He gives the example of the situation in the Faroe Islands.

"The population of the Faroes has the same ancestry as that of the Scandinavian countries, where there has been a high incidence of MS. But there was no case of MS documented in the Faroes until 1943, when British troops occupied the country. This coincided with the first of 4 documented MS epidemics within native Faroe people."

The other piece of information that points to a trigger, Dr. Vartanian explained, is the pathology of the very first lesions at the earliest stages of the disease, which shows disruption of the normal integrity of the blood-brain barrier, oligodendrocyte apoptosis with preservation of myelin, and early microglial activation, but no T cells or B cells. "This suggests that the initial lesions are not formed by an autoimmune response but rather by a toxin or virus targeting oligodendrocytes."

"While it is clear that new MS disease activity requires an environmental trigger, the identity of this trigger has eluded the MS scientific community for decades," Dr. Vartanian says.

He noted that it has previously been suggested that MS may be related in some way to sheep and that organisms commonly found in sheep may be a trigger. C perfringens type B is one such organism, and he is proposing that the toxin it produces could be the trigger.

"C perfringens B is found in soil and is not normally present in humans. It can live the gastrointestinal tract of grass-eating animals, where it can grow fast and make a toxin that causes neurological symptoms. In humans, who have a linear GI [gastrointestinal] tract, it does not grow well. Our hypothesis is that in some environmental conditions, this bacterium takes up residence in the human gut and makes this toxin."

Higher levels of cognitive activity in childhood, middle age, and old age were associated with slower rate of cognitive decline, after controlling for disease pathology on brain autopsy, a new study has shown.

Lead author Robert S. Wilson, PhD, Rush University Medical Center, Chicago, Illinois, told Medscape Medical News that it has been fairly well established that reduced cognitive activity is associated with an increased rate of cognitive decline, but what has not been known is which comes first.

"This basic association has been out there for several years, but it has been suggested that the reduced cognitive activity could be just a sign of disease pathology. So if you're developing Alzheimer's, you will be less likely to engage in cognitive activities. But in our study, we have actually controlled for disease pathology, and we still see a strong association, so that blows that theory out of the water," he said

"We have proved for the first time that increased cognitive activity has an association with reduced cognitive decline independent of cognitive-related pathology. I think it is likely to be causal, but as this is an observational study, we can't make that leap definitely. But as it is virtually impossible to conduct a prospective, randomized clinical trial of a lifestyle factor such as cognitive activity, we have to look at observational studies for this information," Dr. Wilson added.

"Our results suggest that it is a good idea to start doing some sort of cognitive activity every day if you're not already doing it."

Common neuro-ophthalmologic manifestations of multiple sclerosis (MS) are unilateral vision loss due to optic neuritis (ON) and oscillopsia due to nystagmus and diplopia (eg, internuclear ophthalmoplegia [INO], ocular motor palsy). Other common neurologic symptoms are sensory disturbances, motor weakness, and trigeminal neuralgia. Patients with ophthalmic symptoms consistent with a possible MS attack should therefore be questioned about historical features that may be suggestive of MS (eg, prior neurologic deficit, prior diplopia or loss of vision, prior neuroimaging studies).

Diplopia may be due to an INO or an ocular motor cranial neuropathy, typically a sixth nerve palsy; third and fourth cranial neuropathies are uncommon in MS. In an INO, an adduction deficit of the ipsilateral eye is present, with horizontal gaze nystagmus in the contralateral abducting eye. The lesion involves the medial longitudinal fasciculus (MLF). The occurrence of bilateral INO is considered to be highly suggestive of MS, especially in young patients.

A new-onset acquired pendular nystagmus is relatively common, but upbeat, downbeat, convergence-retraction, and other forms of nystagmus may occur as well, depending on the location of the demyelinating lesion.

Combinations of deficits may also occur in MS, including the following:

Horizontal or vertical gaze palsies

Wall-eyed bilateral INO (WEBINO)

Wall-eyed monocular INO (WEMINO)

Paralytic pontine exotropia

One-and-a-half syndrome

The classic clinical picture of MS is one of multiple neurologic symptoms disseminated in space and time. More specifically, over time, patients manifest episodic neurologic dysfunction due to inflammation in different regions of the central nervous system (CNS).

Special considerations

Patients with ON should be cautioned to avoid work and other activities that may require greater visual skills than they possess. Use of machinery, heavy equipment, or sharp instruments, as well as other visually demanding activities, may have to be avoided until the patient recovers sufficient vision, stereovision, color vision, and contrast acuities.

Patients should know that vigorous physical activity, hot baths, and other activities that raise their core body temperature might result in temporary decreases in vision because of the Uhthoff phenomenon.

Patients with ON, particularly those with abnormal findings on magnetic resonance imaging (MRI), should be offered the opportunity to consult with a neurologist regarding the possibility of MS. A formal consultation with a neurologist is indicated especially if the referring physician is unable or unwilling to discuss the complex issues surrounding the evaluation, treatment, and prognosis of MS.

People with multiple sclerosis (MS) tend to have their first symptoms between the ages of 20 and 40. Usually the symptoms get better, but then come back. Some may come and go, while others linger.

The unpredictable course of MS can make it hard to get a diagnosis quickly. Keep track of your symptoms to help your doctor know whether MS or another condition is to blame.

You can manage and treat most symptoms of MS.

Whether you have a diagnosis or are worried about symptoms, know that MS doesn't have to control your life. You can work with your doctor to treat and manage your symptoms so you can stay healthy and continue to live the life you want.

Early Symptoms of MS

Blurred or double vision

Thinking problems

Clumsiness or a lack of coordination

Loss of balance

Numbness

Tingling

Weakness in an arm or leg.

No two people have exactly the same symptoms of MS.

You may have a single symptom, and then go months or years without any others. A problem can also happen just one time, go away, and never return. For some people, the symptoms become worse within weeks or months.

Wednesday, October 23, 2013

New research concludes that acupuncture “significantly improves the quality of life” for multiple sclerosis patients. Multiple sclerosis is an inflammatory disease of the brain and spinal cord that causes a wide range of symptoms including pain, numbness, visual problems, speech problems, cognitive impairment, muscle spasms and depression. Acupuncture was shown to reduce both pain and depression. In addition, acupuncture significantly improved mobility in the eyes.

Acupuncture at YintangAnother group in the study received sham acupuncture, which only simulates acupuncture therapy. The sham acupuncture group did not show sustained improvement in pain, depression and eye mobility. By contrast, the true acupuncture group showed improvement in all three areas and also demonstrated an overall improvement in the quality of life. Other notable improvements in the acupuncture group included improved sleep and appetite. Acupuncture also reduced incontinence, constipation and leg spasms.

All participants in the study, in both the sham and true acupuncture groups, were receiving care under a doctor including the immunomodulatory drugs interferon-beta and glatiramer acetate. No subject in the study received acupuncture prior to the investigation and all subjects were randomized into a true acupuncture group and a sham acupuncture group.

The true acupuncture group received treatment at acupoints ST36 (Zusanli), SP6 (Sanyinjiao), LI4 (Hegu), LI11 (Quchi) and Yintang (EX-HN3). Electroacupuncture was applied to all points, except for Yintang, at 4 Hz with a pulse width of 0.5ms. The sham acupuncture group was needled one centimeter laterally to the true acupuncture points at a superficial needle insertion depth of less than 0.2cm with no electrical stimulation.

An interesting clinical result presented during the investigation. The sham acupuncture group showed temporary pain reduction. However, only the true acupuncture group demonstrated pain reduction measured at six months following the acupuncture treatments.

- See more at: http://www.healthcmi.com/Acupuncture-Continuing-Education-News/643-acupunctureceumultiplesclerosispaindepression#sthash.dtNohFAJ.dpuf

When Lucy Walter was diagnosed with multiple sclerosis (MS) in 2004, she was told she'd better start preparing for life in a wheelchair.

The 51-year-old had been suffering excruciating migraines and stomach cramps since her mid-30s, but despite constant trips to hospital, doctors couldn't work out what was wrong. They even tried removing her gall bladder, to no avail.

"I was terrified," Walter told MSN.

"I was being put on powerful pain relief but it wasn't working because MS is actually just the misfiring of the nerves -- it's not pain as your body normally recognises it."

A mother of three, she suddenly found herself being cared for by her husband and three children.

"It affected my optic nerve and sometimes I couldn't see so my teenage son had to carry me up the stairs," she said.

"One doctor implied I needed to see a psychologist because it was something in my head, but I knew that wasn't the case -- I wasn't doing it for attention."

It wasn't until she saw a different GP that she started to get some answers to the unexplained and seemingly unrelated symptoms she'd been suffering for five years.

"I was sent to a specialist and I was finally diagnosed with MS," she said.

"While it wasn't a good diagnosis, in some ways it was a relief to understand what was happening to my body. They suggested that within five years I would have no mobility."

Multiple sclerosis affects the central nervous system, interfering with the transmission of nerve impulses throughout the brain, spinal cord and optic nerves.

Its symptoms are varying and unpredictable, which is why it took doctors a long time to diagnose Walter.

Walter was advised to start preparing for life in a wheelchair.

"I was already using a cane and we lived in a three-storey house," she said.

"We realised that our lifestyle wouldn't support a wheelchair so my husband and I sold our home in Brisbane to move to the Sunshine Coast hinterland to reduce the stress levels in our life and also live in a single level home where I could get around in a wheelchair easily."

From the outset, Walter was hesitant about taking drugs for MS.

"The drugs I had been given had made me chronically ill," she said.

"None of the drugs had been proven to help MS and I wanted to do something that would be holistic."

About six months after her diagnosis, Walter was introduced to the idea of eating plant-based foods to help her body cure itself.

"There is a lot of evidence that animal-based products tend to trigger things like cancer and it makes your body an acidic environment," she said.

"I started to do a lot of research and my husband and I decided to try going 100 percent raw."

To their surprise, her symptoms started reducing.

"We did some pretty radical things … once we did a 10-day water fast to rest my body," she recalls.

"It became very apparent that it was the raw food diet that was the catalyst for my improvement. It became a very easy process to stick to and before I knew it, I was planting a vegie garden and now I have a very fit and healthy life."

Now Walter is on a "high raw" diet, where the bulk of her diet is raw plant-based foods.

That means lots of green smoothies using produce from her vegetable garden, as well as fresh meals, such as marinated mushrooms, zucchini pasta and kale salads.

"If it comes in a packet, I tend not to eat it," she said.

"Cooking lowers the nutrition. The vitamin C and B vitamins die at a certain temperature when cooking, and the heat starts to change the nutritional structure of the food. If you are trying to heal, your body needs all the nutrition to start to recover."

These days, Walter's MS symptoms have all but disappeared. "Occasionally I might get a phantom pain but that is so rare," she said.

One of the most common bacteria in the world may be a trigger for multiple sclerosis, say researchers from Weill Cornell Medical College and Rockefeller University. They noted in the journal PLOS ONE that the bacterium Clostridium C. perfringens, commonly found in soil, has some dangerous forms that can destroy the neurological system.

Clostrodium perfringens has five types: A through E. Type A is in the human gastrointestinal tract and is harmless. However, types B and D carry a gene, an epsilon toxin, which can have harmful effects. These genes release a protoxin that turns into a potent epsilon toxin in the GI tract that travels via the blood stream to the brain, damaging brain blood vessels and myelin. The results are symptoms that are similar to MS.

Blood, spinal fluid, and stool samples were taken from MS patients to test for antibody reactivity to epsilon toxin. These samples were compared to patients without MS. Researchers discovered that epsilon toxin antibodies were 10 times higher in MS patients than in those without MS.

THE WOODLANDS, Texas, Oct 21, 2013 (BUSINESS WIRE) -- Opexa Therapeutics, Inc., a biotechnology company developing Tcelna(R), a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today announced that the Company has been featured in Neurology Reviews. The article, titled "Regulation May Be Impaired in Patients With Secondary Progressive MS," was written by Erik Greb, the publication's senior associate editor, and presents data from Opexa's Immune Monitoring program that is part of its ongoing Phase IIb Abili-T trial in Secondary Progressive MS (SPMS).

The article presents baseline data on Opexa's Immune Monitoring Program that was previously presented at the 2013 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) meeting. The immune monitoring data will be used to assess the impact of Tcelna in SPMS patients compared to patients receiving placebo. Opexa's data supports the finding that immune regulation appears to be impaired in individuals with SPMS. Opexa characterized the status of patients with SPMS entering the Phase IIb trial at baseline and compared the data sets to those of healthy donors. The results showed a marked difference between key biomarkers of inflammation, specifically TR1 and Treg cells, in patients suffering from SPMS versus healthy donors. The results corroborated findings in the literature and provide support for the assays being utilized by Opexa for the immune monitoring program.

"As part of our Phase IIb Abili-T trial, we are undertaking a comprehensive immune monitoring program for all patients enrolled in the study," commented Donald Healey, PhD, Chief Scientific Officer at Opexa. "The goals of this program are to further understand the biology behind the mechanism of action for Tcelna and to possibly identify novel biomarkers that are dominant in the pathophysiology of SPMS patients.

SYMPTOMS of MS

In multiple sclerosis , damage to the myelin in the central nervous system (CNS), and to the nerve fibers themselves, interferes with the transmission of nerve signals between the brain and spinal cord and other parts of the body. This disruption of nerve signals produces the primary symptoms of MS, which vary depending on where the damage has occurred.

Over the course of the disease, some symptoms will come and go, while others may be more lasting.

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